OLANZAPINE MABO 15 mg ORALLY DISINTEGRATING TABLETS

Introduction

Package Leaflet: Information for the User

Olanzapine MABO 15 mg orodispersible tablets EFG

Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Olanzapine MABO is and what it is used for
2. What you need to know before you take Olanzapine MABO
3. How to take Olanzapine MABO
4. Possible side effects
5. Storage of Olanzapine MABO
6. Contents of the pack and other information

1. What Olanzapine MABO is and what it is used for

Olanzapine MABO tablets belong to a group of medicines called antipsychotics.

Olanzapine MABO is used to treat:

• Schizophrenia, a disease with symptoms such as hearing, seeing or feeling things that are not real, mistaken beliefs, unusual suspiciousness, and a tendency to withdraw. People suffering from these diseases may also be depressed, anxious or tense.

• Moderate to severe manic disorder, characterized by symptoms such as excitement or euphoria, a disorder characterized by symptoms such as feeling euphoric, having excessive energy, a need to sleep much less than usual, talking very quickly with flight of ideas and, sometimes, considerable irritability. It is also a mood stabilizer that prevents the appearance of extreme variations in mood associated with this disease.

• This medicine has been shown to prevent the recurrence of these symptoms in patients with bipolar disorder whose manic episodes have responded to treatment with olanzapine.

2. What you need to know before you take Olanzapine MABO

Do not take Olanzapine MABO

• if you are allergic to Olanzapine or any of the other ingredients of this medicine (listed in section 6). The allergic reaction may manifest as a rash, itching, swelling of the face or lips or difficulty breathing. If this happens to you, tell your doctor.
• if you have previously been diagnosed with narrow-angle glaucoma (increased pressure in the eye).

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine:

• the use of this medicine is not recommended in elderly patients with dementia as it may have serious side effects.
• medicines of this type may cause unusual movements, especially in the face or tongue. If this happens to you after taking Olanzapine, tell your doctor.
• very rarely, medicines of this type produce a combination of fever, rapid breathing, sweating, muscle stiffness and a state of obnubilation or somnolence. If this happens to you, contact your doctor immediately.
• a weight gain has been observed in patients taking this medicine. You and your doctor should check your weight regularly. If necessary, your doctor can help you plan a diet or consider referring you to a nutritionist.
• high levels of sugar and fats (triglycerides and cholesterol) have been observed in the blood of patients taking this medicine. Your doctor should perform blood tests to control your blood sugar and fat levels before you start taking olanzapine and regularly during treatment.

If you suffer from any of the following diseases, tell your doctor as soon as possible:

• stroke or transient lack of blood flow to the brain (transient symptoms of stroke)
• Parkinson's disease
• prostate problems
• intestinal blockage (paralytic ileus)
• liver or kidney disease
• blood disorders
• heart disease
• diabetes
• seizures

If you suffer from dementia, you or your caregiver or family member should inform your doctor as you may have serious side effects.

If you have ever had a stroke or a lack of blood flow to the brain.

As a routine precaution, if you are over 65 years old, it would be advisable for your doctor to check your blood pressure.

Children and adolescents

Patients under 18 years of age should not take Olanzapine.

Other medicines and Olanzapine Mabo

Only take other medicines at the same time as Olanzapine if your doctor authorizes it. You may feel a certain feeling of sleepiness if you combine Olanzapine with antidepressants or medications for anxiety or that help you sleep (tranquilizers).

Tell your doctor or pharmacist if you are taking or have recently taken any other medicine, even those purchased without a prescription.

Tell your doctor especially if you are taking

• medication for Parkinson's disease.
• carbamazepine (an antiepileptic and mood stabilizer), fluvoxamine (an antidepressant) or ciprofloxacin (an antibiotic). You may need to change your dose of this medicine.

Taking Olanzapine with food and drinks

Olanzapine MABO tablets can be taken with or without food.

You should not drink alcoholic beverages during treatment with Olanzapine MABO orodispersible tablets. The combination of Olanzapine and alcohol may cause sleepiness.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or plan to become pregnant, consult your doctor before using this medicine. You should not take this medicine when you are breastfeeding, as small amounts of olanzapine may pass into breast milk.

The following symptoms may occur in newborn babies of mothers who have been treated with olanzapine in the last trimester of pregnancy (last three months of pregnancy):

tremors, stiffness and/or muscle weakness, sleepiness, agitation, breathing problems, and difficulty feeding. If your baby develops any of these symptoms, you should contact your doctor.

Driving and using machines

There is a risk of sleepiness when you are taking Olanzapine. If this happens to you, do not drive vehicles or use machinery. Consult your doctor.

Olanzapine MABO contains aspartame

This medicine contains 8.4 mg of aspartame in each tablet.

Aspartame contains a source of phenylalanine that may be harmful in case of phenylketonuria (PKU), a rare genetic disease in which phenylalanine accumulates because the body is unable to eliminate it properly.

3. How to take Olanzapine MABO

Follow exactly the administration instructions of Olanzapine MABO indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Your doctor will indicate how many tablets of this medicine you should take and for how long. The daily dose of Olanzapine ranges from 5 to 20 mg. Consult with your doctor if you suffer from symptoms again, but do not stop taking Olanzapine unless your doctor tells you to.

You should take your Olanzapine tablets once a day, following your doctor's instructions. Try to take the tablets at the same time every day. Olanzapine tablets are for oral administration.

Do not interrupt treatment when you feel better. It is very important that you continue taking Olanzapine while your doctor tells you to.

Olanzapine MABO tablets dissolve easily, so they should be handled with care. Do not handle the tablets with wet hands because they can break.

1. Hold the blister by the ends and separate one of the cells, breaking it gently through the perforations that surround it.

1. Gently remove the back of the cell.

1. Carefully remove the tablet.

1. Place the tablet in your mouth. It will dissolve directly in your mouth, so it will be very easy to swallow.

You can also put the tablet in a cup or glass filled with water, orange juice, apple juice, milk, or coffee, stirring. With some beverages, the mixture may change color and take on a cloudy appearance. You should drink it immediately.

If you take more Olanzapine MABO than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested. It is recommended to take the package and the package leaflet of the medicine to the healthcare professional.

Patient who have taken more Olanzapine than they should have experienced the following symptoms: rapid heartbeat, agitation/aggression, speech problems, unusual movements (especially of the face and tongue), and a reduced level of consciousness. Other symptoms may include: acute confusion, seizures (epilepsy), coma, a combination of fever, rapid breathing, sweating, muscle stiffness, and a state of obnubilation or somnolence, slowing of respiratory rate, aspiration, increased or decreased blood pressure, and abnormal heart rhythms. Contact your doctor or go to the hospital immediately. Show the doctor the package with the tablets.

If you forget to take Olanzapine MABO

If you forget to take a dose of Olanzapine, continue treatment with the normal dose. Do not take a double dose to make up for forgotten doses.

If you stop taking Olanzapine MABO

Do not stop treatment without consulting your doctor first, even if you feel better. It is very important that you continue taking this medicine while your doctor tells you to. Stopping treatment should be done gradually and always following the doctor's instructions.

If you stop taking this medicine suddenly, symptoms such as sweating, insomnia, tremors, anxiety, or nausea and vomiting may appear. Your doctor may suggest that you gradually reduce the dose before stopping treatment.

If you have any other questions about the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Olanzapine can cause side effects, although not everybody gets them.

Contact your doctor immediately if you have:

-unusual movements (a frequent side effect that can affect up to 1 in 10 people), especially of the face or tongue, tremors.

-blood clots in the veins (a rare side effect that can affect up to 1 in 100 people), especially in the legs (symptoms include swelling, pain, and redness in the leg), which can travel through the blood to the lungs, causing chest pain and difficulty breathing. If you experience any of these symptoms, go to the doctor immediately.

-a combination of fever, rapid breathing, sweating, muscle stiffness, and a state of obnubilation or somnolence (the frequency cannot be estimated from the available data)

Very common side effects (which can affect more than 1 in 10 people) include weight gain; sleepiness; and increased prolactin levels in the blood. In the early stages of treatment, some people may feel dizzy or faint (with slower heartbeats), especially when getting up from a lying or sitting position. This feeling usually disappears on its own, but if it does not, consult your doctor.

Common side effects (which can affect up to 1 in 10 people) include changes in the levels of some blood cells, circulating lipids, and temporary increases in liver enzymes at the start of treatment; increased blood sugar and urine levels; increased uric acid and creatine phosphokinase levels in the blood; increased appetite; dizziness; agitation; tremors; unusual movements (dyskinesia); constipation; dry mouth; skin rash; loss of strength; excessive fatigue; fluid retention that causes swelling of the hands, ankles, or feet; fever; joint pain; and sexual dysfunctions such as decreased libido in men and women or erectile dysfunction in men.

Rare side effects (which can affect up to 1 in 100 people) include hypersensitivity (e.g., inflammation of the mouth and throat, itching, skin rash); diabetes or worsening of diabetes, occasionally related to ketoacidosis (acetone in blood and urine) or coma; seizures, in most cases related to a history of seizures (epilepsy); muscle stiffness or spasms (including eye movements); restless legs syndrome; speech problems; stuttering; slow pulse; sensitivity to sunlight; nosebleeds; abdominal distension; memory loss or forgetfulness; urinary incontinence; loss of urination ability; hair loss; absence or decrease of menstrual periods and changes in the mammary gland in men and women, such as abnormal milk production or abnormal growth, excessive salivation.

Very rare side effects (which can affect up to 1 in 1000 people) include a drop in normal body temperature; abnormal heart rhythm; sudden unexplained death; pancreatitis, which causes severe stomach pain, fever, and discomfort; liver disease, with yellowing of the skin and the white areas of the eyes; muscle disorder that presents as unexplained pain and prolonged and/or painful erections.

Very rare side effects include severe allergic reactions such as drug reaction with eosinophilia and systemic symptoms (DRESS). Initially, DRESS manifests with symptoms similar to the flu, with a rash on the face, and later, with an extensive rash, fever, enlarged lymph nodes, elevated liver enzymes observed in blood tests, and an increase in a type of white blood cell (eosinophilia).

During treatment with Olanzapine, elderly patients with dementia may suffer from stroke, pneumonia, falls, extreme fatigue, visual hallucinations, a rise in body temperature, skin redness, and walking problems. Some deaths have been reported in this particular group of patients.

Olanzapine may worsen symptoms in patients with Parkinson's disease.

Reporting of side effects:

If you experience any side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines (Website: www.notificaram.es) By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Olanzapine MABO

Keep this medicine out of the sight and reach of children.

Storage conditions:

Blister: No special storage conditions are required.

Do not use Olanzapine MABO after the expiration date stated on the package. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packages and medicines you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packages and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Olanzapine MABO

• The active substance is Olanzapine. Each orodispersible tablet contains 15 mg of Olanzapine.

• The other ingredients (excipients) are: heavy magnesium carbonate, microcrystalline cellulose, crospovidone, microcrystalline cellulose, and guar gum, aspartame E951, low-substitution hydroxypropyl cellulose, orange flavor, anhydrous colloidal silica, magnesium stearate, L-methionine.

Appearance of the product and contents of the pack

Olanzapine MABO 15 mg is presented in the form of orodispersible tablets. The tablets are yellow, round, and biconvex, marked with an 'O2' on one face.

Package sizes:

Non-divisible blister pack in individual doses of Al/Al with 28 tablets.

Perforable blister pack divisible into individual doses of Al/Al with 28 tablets.

Marketing authorization holder

MABO-FARMA S.A.

Calle Vía de los Poblados, 3,

Edificio 6, 28033 Madrid,

Spain.

Manufacturer

Actavis Ltd.

BLB016 Bulebel Industrial Estate

Zejtun ZTN 3000

Malta

Date of last revision of this leaflet: September 2024

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/